# NIOX VERO Sensor 500

> Active: European Union and United States. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/niox-12-1650>
- Manufacturer: [Circassia AB](https://devicerts.com/manufacturers/circassia-ab) (Sweden, FDA 510(k) applicant)
- Device class: Class B (EU IVDR); Class II (US FDA)
- FDA product code: MXA
- EMDN: W0201069085 VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - CONSUMABLES
- GMDN: Nitrogen monoxide analyser (60354)

## Registrations and authorizations

- **EUDAMED** · CE/IVDR · European Union · IX 1379539-1 · issued 2026-07-06 · expires 2031-06-11 · status: Active
- **EUDAMED** · CE/IVDR · European Union · Basic UDI-DI 735004703NIOXSENSORG2 · UDI-DI 07350047030281 · registered 2026-06-19 · status: Active
- **GUDID** · GUDID listing · United States · UDI-DI 07350047030281 · listed 2016-09-21 · status: Listed (GUDID: in commercial distribution)
- **GUDID** · FDA 510(k) · United States · K133898 · decision 2014-11-06 · decision SESE · status: Active · from GUDID

## EU certificates

- IX 1379539-1 · Technical documentation · IVDR · notified body TÜV Rheinland LGA Products GmbH · issued 2026-07-06 · expires 2031-06-11 · status: issued

## Recalls

No recall on record.

## Identity

- Trade name: NIOX [EUDAMED, FDA GUDID (AccessGUDID)]
- Generic name: Nitrogen monoxide analyser [FDA GUDID (AccessGUDID)]
- Device name: NIOX Sensor [EUDAMED]
- Model / Ref / Catalog: 12-1650 [EUDAMED, FDA GUDID (AccessGUDID)]; VERO Sensor 500 [FDA GUDID (AccessGUDID)]

## Identifiers

- Primary DI / UDI-DI: 07350047030281 [EUDAMED, FDA GUDID (AccessGUDID)]
- Basic UDI-DI: 735004703NIOXSENSORG2 [EUDAMED]
- 510(k) Number: K133898 [FDA GUDID (AccessGUDID)]
- FDA product code: MXA [FDA GUDID (AccessGUDID)]
- EMDN code: W0201069085 [EUDAMED]
- GMDN term: Nitrogen monoxide analyser (60354) [FDA GUDID (AccessGUDID)]

## Classification

- Device class: Class B [EUDAMED]; Class II [FDA GUDID (AccessGUDID)]
- Regulation number: 862.3080 [FDA GUDID (AccessGUDID)]
- EU registration type: Standard device [EUDAMED]
- EU market of registration: Sweden [EUDAMED]
- GUDID distribution status: In Commercial Distribution [FDA GUDID (AccessGUDID)]

## Properties

- Contains latex: Yes [FDA GUDID (AccessGUDID)]
- Reagent: Yes [EUDAMED]
- Near-patient testing: Yes [EUDAMED]
- Professional testing: Yes [EUDAMED]
- Prescription use: Yes [FDA GUDID (AccessGUDID)]
- Serial number: Yes [FDA GUDID (AccessGUDID)]
- Expiration date: Yes [FDA GUDID (AccessGUDID)]
- Supplied sterile: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Sterilise before use: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Single use: No [FDA GUDID (AccessGUDID)]
- Implantable: No [FDA GUDID (AccessGUDID)]
- Contains human tissues or cells: No [EUDAMED]
- Contains animal tissues or cells: No [EUDAMED]
- Contains substances of microbial origin: No [EUDAMED]
- IVD kit: No [EUDAMED]
- Self-testing: No [EUDAMED]
- Companion diagnostics: No [EUDAMED]
- IVD instrument: No [EUDAMED]
- New device: No [EUDAMED]
- Over-the-counter: No [FDA GUDID (AccessGUDID)]
- Convenience kit: No [FDA GUDID (AccessGUDID)]
- Combination product: No [FDA GUDID (AccessGUDID)]
- HCT/P: No [FDA GUDID (AccessGUDID)]
- Premarket exempt: No [FDA GUDID (AccessGUDID)]
- Lot / batch number: No [FDA GUDID (AccessGUDID)]
- Manufacturing date: No [FDA GUDID (AccessGUDID)]

## Source and citation

- Cite as: NIOX VERO Sensor 500, Circassia AB. deviCERTS medical device catalogue. https://devicerts.com/devices/niox-12-1650 (data as of 2026-11-15).
- Data sources: [FDA GUDID (AccessGUDID)](https://accessgudid.nlm.nih.gov/), [EUDAMED](https://ec.europa.eu/tools/eudamed)
- Registry records last synced: 2026-10-23
- Statuses computed as of: 2026-11-15
- JSON: <https://devicerts.com/devices/niox-12-1650.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/devices/niox-12-1650
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.